REFLEX(R) ECA— 510(k) K924929

Substantially Equivalent

Richard-Allan Medical

FDA 510(k) clearance K924929 for REFLEX(R) ECA, Substantially Equivalent on 1993-07-21. Applicant: Richard-Allan Medical. Device class: 1.

Clearance details

Applicant: Richard-Allan Medical
Product code: Code HBT
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-09-30
Decision date: 1993-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, US

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Recent devices under product code HBT

K896262 — TITANIUM LIGATING CLIPS1990-01-02
K862696 — TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP1986-07-30
K800318 — DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI1980-03-10

More clearances from Richard-Allan Medical

K942207 — REFLEX INS INSUFFLATION NEEDLE1994-05-27
K935105 — REFLEX ESP WITH FINGER SWITCHES1994-02-22
K933508 — REFLEX SDD SURGICAL STAPLER1993-11-23
K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)1993-11-19
K924881 — REFLEX(R) ESP1993-07-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.